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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE

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MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE Back to Search Results
Model Number 4FC12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemoptysis (1887); Great Vessel Perforation (2152); Blood Loss (2597)
Event Date 10/08/2018
Event Type  Injury  
Manufacturer Narrative
Product event summary: the data files were returned and analyzed. The data files showed at least 5 injections were performed with balloon catheter 2af283 with lot number 75268 with system notice 50032 ¿the safety system detected a compromised outer vacuum triggered¿ on one injection on the date of event. This system notice is not related to the reported clinical issue. Clinical issues were encountered during the procedure. The sheath was not returned for investigation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure, it was noted that the physician had a difficult time finding the right inferior pulmonary vein (ripv) and the mapping catheter may have entered into an intermediate small right pulmonary vein. Soon after, the patient started to cough and the nurse noticed blood was being expectorated. The physician stopped the catheter manipulation to check on the patient and consulted with vascular experts. Medication was administered to reverse the bleeding. The bleeding stopped quickly and the patient stopped coughing. The case was aborted. The patient was ok and a scan was performed which revealed some bleeding around the small intermediate right pulmonary vein that was stable. No further patient complications have been reported as a result of this event. Additional information reported that a perforation was suspected due to the strong push on the mapping catheter into the small vein. Furthermore, it was confirmed that when the perforation occurred, the sheath, balloon catheter, and mapping catheter were all in the heart.
 
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Brand NameFLEXCATH ADVANCE STEERABLE SHEATH
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA H9R 5Z8
Manufacturer (Section G)
MEDTRONIC CRYOCATH LP
9000 autoroute transcanadienne
pointe-claire,qc H9R 5 Z8
CA H9R 5Z8
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key8043791
MDR Text Key126309164
Report Number3002648230-2018-00788
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/15/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number77285
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/06/2018 Patient Sequence Number: 1
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